AB0611 A RANDOMISED OPEN-LABEL PILOT STUDY OF PROBIOTICS AS AN ADJUNCTIVE THERAPY FOR THE TREATMENT OF SYSTEMIC LUPUS ERYTHEMATOUS (SLE)
Authors: M. S. Mohamed Said, M. Armugam, K. N. Muhammad Nawawi, A. Abdul Wahab, R. Mustafa
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> SLE is a complex inflammatory multiorgan disease that leads to multiple comorbidities and mortality. Probiotics were shown to be successful in lowering the pro-inflammatory cytokines in animal SLE models. <h3>Objectives</h3> This study looked at probiotics' effect on disease activity and pro-inflammatory cytokine interleukin-6 (IL-6) among SLE patients. <h3>Methods</h3> We performed a prospective randomised probiotic controlled analysis of those aged 18 years old and above with mild to moderate disease activity (Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score &lt; 13) visiting Hospital Canselor Tuanku Muhriz (HCTM) SLE clinic between December 2021 to February 2022. Patients were prescribed either twice daily probiotics (Lactobacillus spp. and Bifidobacterium spp) to ongoing therapy or maintain ongoing treatment for three months. Baseline and post-treatment Interleukin 6, disease activity score [SLEDAI 2K, Systemic Lupus International Collaborating Clinics American College of Rheumatology (SLICC/ACR) Damage index], and adverse effects following treatment were documented. <h3>Results</h3> There was a 7% reduction of the median (IQR) IL-6 concentration among the probiotic group, 2.28 (4.85)pg/ml at baseline versus 2.12 (2.56) pg/ml at three months; this was not statistically significant (<i>p</i>=0.145). In control group shows increase in level of IL-6 by 48.9% at end of treatment [1.94 (3.59) vs 2.89 (2.83), <i>p</i> = 0.723]. There was a substantial reduction in SLEDAI 2K among the probiotic group by 64.3%, with the mean (SD) baseline of 4.94 (3.09) versus 1.76 (3.15) at three months (<i>p</i>=0.01), while the reduction in the control group were 23.7 %, with the mean(SD) baseline of 4.17 (3.20) versus 3.18 (2.50) at three months (<i>p</i>=0.077). There were no adverse effects noted among the probiotic group. <h3>Conclusion</h3> The use of probiotics reduced clinical disease activity, as demonstrated by the SLEDAI 2K score reduction. The level of IL-6 reduction was insignificant statistically. However, it shows a beneficial effect of probiotics in stabilising IL-6 compared to the control group, which has increased serum IL-6 at three months. The probiotics are relatively safe to consume. These findings warrant further studies with a larger sample size, longer duration, and analysis of multiple cytokines profiles. <h3>References</h3> [1]Shaharir SS, Hussein H, Rajalingham S, Mohamed Said MS, Abdul Gafor AH, Mohd R, et al. Damage in the multiethnic Malaysian systemic lupus erythematosus (SLE) cohort: comparison with other cohorts worldwide. PloS one. 2016;11(11):e0166270. [2]Choi J, Kim ST, Craft J. The pathogenesis of systemic lupus erythematosus—an update. Current opinion in immunology. 2012;24(6):651-7. [3]Weckerle CE, Niewold TB. The unexplained female predominance of systemic lupus erythematosus: clues from genetic and cytokine studies. Clinical reviews in allergy &amp; immunology. 2011;40(1):42-9. [4]Bakar FA, Shaharir SS, Rozita M, Said MSM, Rajalingham S, Kong W. Burden of systemic lupus erythematosus on work productivity and daily living activity: A cross-sectional study among malaysian multi-ethnic cohort. Archives of rheumatology. 2020;35(2):205. <h3>Acknowledgements</h3> Faculty of Medicine UKM and Research Ethics Committee. <h3>Disclosure of Interests</h3> Mohd Shahrir Mohamed Said Speakers bureau: Pfizer, Novartis, Zuellig Pharma, Abbvie, Menachi Armugam: None declared, Khairul Najmi Muhammad Nawawi: None declared, Asrul Abdul Wahab: None declared, Ruslinda Mustafa: None declared.